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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tympanostomy
510(k) Number K071178
Device Name OTOMEDICS SOFT TYMPANOSTOMY TUBE
Applicant
OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD.
20 HATA'AS ST.
KFAR SABA,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD.
20 HATA'AS ST.
KFAR SABA,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number874.3880
Classification Product Code
ETD  
Date Received04/27/2007
Decision Date 06/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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